WHO ICTRP trial

Randomized study to evaluate the efficacy of therapy with Brentuximab…

EUCTR2019-002746-21-GR · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2019-002746-21-GR
Public title Randomized study to evaluate the efficacy of therapy with Brentuximab Vedotin-Etoposide, Methylprednisolone, Cisplatin and Cytarabine (ESHAP) vs ESHAP in patients with Hodgkin's Lymphoma, followed by treatment with Brentuximab Vedotin in patients who reach metabolic response after salvage therapy
Scientific title A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed / Refractory Classical Hodgkin’s Lymphoma, Followed by Brentuximab Vedotin Consolidation (instead of Autologous Hematopoietic Stem Cell Transplantation) in Those who…
Primary sponsor Grupo Español de linfomas y trasplante autologo de medula osea (GELTAMO)
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Greece;Austria;Israel;Spain;Croatia
Conditions Patients with Relapsed /Refractory Classical Hodgkin's Lymphoma MedDRA version: 20.1 Level: LLT Classification code 10080208 Term: Classical Hodgkin lymphoma System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Blood and…
Interventions Trade Name: Adcetris Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Brentuximab vedotin Other descriptive name: BRENTUXIMAB VEDOTIN Concentration unit: mg milligram(s) Concentration type: equal Concentration…
Registration date Apr 18, 2022
Target size 150
Secondary IDs GELTAMO18-HL;2019-002746-21-ES
Registry page clinicaltrialsregister.eu

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